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Royal Cornwall Hospitals NHS Trust MAJ Il y a 4 ans

Rehabilitation enablement in chronic heart failure Background and study aims This study forms one part of a wider research project led by a research team based in Cornwall, who are interested in improving the care provided to people with heart failure. The overall aim of the project is to develop and test a new self-help manual (the HF manual) for people with heart failure and for the caregivers that help them to manage the condition. The HF Manual has been designed for patients with a type of heart failure referred to as ‘heart failure with reduced ejection fraction’. In this type of heart failure, the heart muscle does not contract effectively and less blood is pumped out to the body. It is hoped that the HF Manual will also be appropriate for patients with another type of heart failure referred to as ‘heart failure with preserved ejection fraction (HFpEF)’. In this type of heart failure, the heart muscle contracts normally but does not relax as it should after contraction. The purpose of this study is to see if a larger study is feasible in patients with HFpEF. We will assess the suitability of the HF Manual for HFpEF patients, and test our procedures for collecting research data, in preparation for a larger study in the future. Who can participate? Patients aged 18 or over with HFpEF. What does the study involve? Patients will be allocated to one of two groups: patients in the control group will continue to receive their usual care, while patients in the intervention group will receive the new HF Manual in addition to their usual care. We don’t know if the new manual is effective or not but we can find out by comparing information collected from people in both groups. We know that heart failure affects the lives not just of the people with the condition, but can also impact those family members and friends who help to support them. If patients have a family member or friend who provides unpaid support to help them manage the condition, they are also invited to take part in the study as a caregiver. What are the possible benefits and risks of participating? Participants will be helping to evaluate the effectiveness of the HF Manual. Although participants may not benefit personally, the information gathered from their participation in the study may help to improve the rehabilitation of patients with heart failure in the future. Participants are not expected to be harmed in any way by taking part in this study. When blood samples are taken, participants may feel some discomfort at the puncture site, although this is usually short lived. A total of about 8 ml (less than one tablespoon) of blood will be collected over the study period. Blood sampling can occasionally lead to localised bruising and discomfort and (rarely) infection at the site where the blood was taken. If participants are in the intervention group and receive the HF Manual, they may be asked questions about their experiences with heart failure and its impact on their day-to-day life which might be upsetting. This may be whilst working through some of the sections of the HF Manual with the facilitator and during the interviews with members of the research team if they choose to take part. The facilitators and researchers involved in the study are professionally trained and will ask questions sensitively. Participants do not have to answer any questions which cause them to feel upset. If participants do get upset, the facilitators and local researchers can refer patients to the heart failure nursing service or their GP. Attendance at research clinics may incur an expense to participants in the first instance. However, any travel expenses for taking part in this study, including those incurred through use of their own vehicle, will be reimbursed at public transport rates. Where is the study run from? NHS Tayside (UK). When is the study starting and how long is it expected to run for? June 2015 to October 2016 Who is funding the study? National Institute for Health Research (UK) Who is the main contact? Prof. Rod Taylor

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University of Southampton (UK) MAJ Il y a 4 ans

Chinese herbal medicine in the treatment of women with recurrent urinary tract infections Background and study aims In the UK urinary tract infections (UTIs) are the most common infection that women come to the GP surgery with. About 40-50% of women experience this at least once in their lifetime. This accounts for between 1-3% of all consultations in general practice. Repeated urinary tract infections (RUTIs) are commonly defined as three episodes of UTI in the last 12 months or two episodes in the last 6 months. Between 20-30% of women who have had one episode of UTI will have a recurrent UTI, and around 25% of these will develop subsequent recurrent episodes. RUTIs can affect the quality of life, and have a high impact on healthcare costs as a result of outpatient visits, diagnostic tests and prescriptions. Whilst antibiotics are effective as a preventative treatment for RUTIs there is increasing concern about microbial resistance to these drugs and side effects of long-term use. Also, between 50-60% of women will become re-infected within 3 months after stopping antibiotics so they are not getting to the root of the problem. Chinese herbal medicine (CHM) has a long history of treating the symptoms of UTIs. In recent years there has been some encouraging research in China looking at the effect of CHM given either on its own or together with antibiotics to help prevent RUTIs. Unfortunately the methodology of most of these studies is poor and we need to conduct a more rigorous clinical study to assess the effect of CHM in preventing RUTIs. This study is the first stage of this process and will assess the feasibility of delivering CHM through GP surgeries to a group of women suffering from RUTIs. We are going to explore whether CHM helps to prevent RUTIs, whether it has any benefits in improving quality of life, and if there are any side effects from CHM treatment. We are also going to evaluate how people with RUTIs feel about taking CHM and whether it is a form of treatment that could be given by GPs or whether it needs to be given by a trained CHM practitioner. Who can participate? Women aged between 18-65 with three or more RUTIs in the previous 12 months. What does the study involve? Patients will be randomly allocated to one of four groups: 1. Active standardised CHM treatment delivered via GPs 2. Placebo standardised CHM treatment delivered via GPs 3. Active individualised treatment delivered via CHM practitioners 4. Placebo individualised treatment delivered via CHM practitioners Standardised CHM treatment will be delivered as herbal capsules via GP practice nurses and will involve the use of fixed herbal formulae for severe episodes and for preventative treatment. These formulae will be developed through expert consultation. They will comprise of three herbs in each formula. A matching placebo (dummy) herbal capsule will be prepared and tested prior to the study. Individualised treatment will be administered by experienced practitioners of CHM and will be delivered as concentrated herbal granules that will be dissolved in hot water and drunk. Treatment will be based on the patient-specific diagnosis made by the practitioner and will vary between patients and over time. What are the possible benefits and risks of participating? The treatment may reduce the frequency and severity of participants’ RUTIs. However, this is something that has not been proven and it is the aim of this research to explore whether CHM can help in these circumstances. In CHM the herbs can cause some digestive upset like temporary nausea or loose bowels. However, these usually only lasts for 2-3 days and generally the herbs are well tolerated. In very rare instances the herbs can cause abnormal liver or kidney function. Blood tests will be conducted at the beginning of the study, after 4 weeks of taking the herbs and again at the end of the trial to measure liver and kidney function and to ensure that the participant can tolerate the Chinese herbs. Where is the study run from? Standardized herbal remedies administered by practice nurses will take place in Hampshire and Dorset. We anticipate that up to eight GP practices will be involved. Individualized herbs administered by CHM practitioners will take place in two complementary medicine clinics. One will be in North London and the other will be in Hove, UK. Trial participants will still require to be referred by their GPs before they can take part in this group of the study. When is the study starting and how long is it expected to run for? The study will run from January to December 2015. Who is funding the study? The National Institute of Health Research (NIHR) (UK). Who is the main contact? Dr Andrew Flower [email protected]

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Record Provided by the NHSTCT Register - 2007 Update - Department of Health MAJ Il y a 4 ans

Screening for health problems and emotional distress in GP clinics Background and study aims GPs are encouraged to screen people for health and emotional problems. However, we know little of how people feel about being screened and the impact of screening on their health and well-being. In order to find this out, we would like to conduct two short interviews with people over the telephone. Who can participate? Patients aged 18 and over at the participating 30 GP practices. What does the study involve? All participants will be randomly allocated to one of two groups. The participants in one group will be asked screening questions related to health and emotional problems whilst those in the other group will be asked similar questions at the follow-up interview in 7-10 days. The order in which people will be asked questions will be determined in advance at random (by chance). Selecting the order in which people are asked questions at random provides the best possible way for us to find out what, if any, effect this has. What are the possible benefits and risks of participating? There is no intended benefit for those people who agree to take part in the study. The main disadvantage of taking part would be the inconvenience of two telephone interviews. These interviews would last no more than 15 minutes and would be held at a time of your choosing. We do not have any evidence that the screening questions you will be asked would cause you any discomfort or distress. However, if the questions cause distress then let us know. A support mechanism is in place. Where is the study run from? Imperial College London (UK). When is the study starting and how long is it expected to run for? From July 2006 to February 2009. Who is funding the study? Brent Primary Care Trust (UK). Who is the main contact? Dr Priya Bajaj [email protected]

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